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The Effect of ShotBlocker and Vibration on Pain During Vaccination

NCT07379034 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-01-30

No results posted yet for this study

Summary

This study was conducted to investigate the effects of ShotBlocker and a vibration pen on pain in infants during routine vaccination. In this randomized controlled trial, 96 healthy infants aged 2-6 months were included. The infants were randomized into three groups: vibration pen, ShotBlocker, and control. Pain was assessed before, during, and after the procedure using the FLACC scale.

Conditions

  • Vaccination
  • Pain
  • Infant
  • Shotblocker
  • Vibration

Interventions

OTHER

ShotBlocker Group

ShotBlocker is a plastic medical device with multiple blunt projections that is applied by pressing on the skin during injection. It aims to reduce pain transmission through activation of the Gate Control Theory by stimulating multiple sensory nerve endings and diverting the infant's attention from the painful stimulus.

OTHER

Vibration Group

The vibration pen is a battery-operated device that delivers high-frequency mechanical vibrations and is applied near the injection site. It aims to reduce perceived pain intensity by stimulating large-diameter nerve fibers and inhibiting pain transmission at the "gate" level.

Sponsors & Collaborators

  • Ataturk University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-01-23
Completion
2026-01-23

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07379034 on ClinicalTrials.gov